Peppermint Oil Pharmacokinetics/Dynamics
- Registration Number
- NCT04497870
- Lead Sponsor
- Baylor College of Medicine
- Brief Summary
In children 7-12 years of age with functional abdominal pain (n=42) determine:
Aim 1 - To examine and characterize the threshold of the exposure (PK) vs. response (PD) relationship of PMO (menthol)
Aim 2 - PD of PMO as assessed by:
1. Microbiome composition (16S RNA sequencing)
2. Transit rate/contractile activity (using the SmartPill®) Aim 3 - Evaluate the potential association between PD response and clinical symptoms (abdominal pain and stooling pattern via validated diary), psychosocial distress (anxiety, depression, somatization), and characterize potential side effects (questionnaire)
- Detailed Description
An initial single-dose PK study will be carried out. Forty-two children (n=21 per dose) will be randomized to receive approximately 10.9 mg·kg-1·d-1 of PMO or to receive approximately 18.2 mg·kg-1·d-1 (1.67-fold the median dose).
Following the single-dose PK study, a PD study will be carried out wherein the subjects will receive their assigned dose of PMO for 7 days.
At baseline (before the PK study) and after the PK study (i.e., during the PD study), subjects will keep a pain and stooling diary, collect stool for microbiome analysis, and swallow a SmartPill to measure gut motility and transit time. At baseline only, anxiety, depression, somatization will be measured. During the PD study, any side effects will be recorded.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Children ages 7-12 years who are able to assent to the procedures
- Able to complete the diaries which have been validated for use in this age range
- The history and medical evaluation reveal no organic reason for the abdominal pain
- The child has abdominal pain that meets the definition of FAP according to pediatric Rome IV
- Ability to understand study procedures and to comply with them for the entire length of the study
- Childrens' body weights will not vary by more than 10-15 kg (so that dose per kg is comparable within the two dosing groups)
- Past bowel surgery
- Documented GI disorders (e.g., Crohn's disease)
- A serious chronic medical condition (e.g., diabetes)
- A weight and/or height < 2 SD for age
- Chronic conditions with GI symptoms (e.g., cystic fibrosis)
- Autism spectrum disorder, significant developmental delay, psychosis, depression, or a history of bipolar disorder
- Antibiotic/probiotic treatment within 2 mo.
- Allergy/sensitivity to PMO or its ingredients
- Inability to swallow the PMO capsule or the SmartPill®
- Inability to speak English - testing materials are available only in this language
- Unable to discontinue laxative, prokinetic, or neuromodulator from 3 wk prior to Visit 1 through the end of the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 540 mg Peppermint oil Peppermint oil at a dose of 180 mg thrice daily orally 900 mg Peppermint oil Peppermint oil at a dose of 180 mg five times daily orally
- Primary Outcome Measures
Name Time Method Gut transit time 2 weeks Gut transit time as a consequence of the administration of peppermint oil at the two doses given.
Gut contractility 2 weeks Gut contractility as a consequence of the administration of peppermint oil at the two doses given.
Pharmacokinetics of peppermint oil 2 weeks Area under the curve
Gut Microbiome composition 2 weeks Gut microbiome composition as determined by 16S sequencing as a consequence of the administration of peppermint oil at the two doses given.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Children's Nutrition Research Center
🇺🇸Houston, Texas, United States